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Pharmaceuticals Regulatory Specialist - وظيفتي
وظائف بيت الأردنوظائف في الاردن

Pharmaceuticals Regulatory Specialist

Pharmaceuticals Regulatory Specialist

الوصف الوظيفي

He/She will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations, starting from preparing the registration files for (Medicine, Supplements, Medical devices) until finalizing the registration with the concerned authority.

Responsibilities and Duties

  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate with suppliers & distributors to prepare the required documents associated with the preparation of regulatory documents or submissions.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Communicate with regulatory agencies that Kepler deals with regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Preparing submissions of license variations and renewals to strict deadlines.
  • Developing and writing clear arguments and explanations for new product licenses and licenses renewals.
  • Providing strategic advice to senior management throughout the development of a new product.

المهارات

We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team! As a Regulatory Affairs Specialist.

· Ideally a bachelor's degree in science areas such as Medical, pharmacy, Veterinary, Dentistry, or any science field.

· At least Two years' experience in the specific role.

· Strong communication & negotiation skills.

· Strong interpersonal skills

· Excellent customer service skills

· Strong problem-solving skills

· Excellent organizational skills

· Highly developed attention to detail

· Strong project management skills

· Ability to work well in a team environment

· Awareness of the legislation governing the approval of products.

تفاصيل الوظيفة

منطقة الوظيفة
عمان, الأردن
قطاع الشركة
صناعة الدواء
طبيعة عمل الشركة
صاحب عمل (القطاع الخاص)
الدور الوظيفي
الطب والرعاية الصحية والتمريض
نوع التوظيف
دوام كامل
الراتب الشهري
غير محدد
عدد الوظائف الشاغرة
1

المرشح المفضل

منطقة الإقامة
عمان,الأردن
الجنس
أنثى
الجنسية
الأردن

التعليم

Pharmacy

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